Associate Director / Director, Global Supply Chain

Q32 BIO is advancing novel therapeutics to treat serious autoimmune and inflammatory disorders. We aim to deliver life-changing treatments for patients with a variety of diseases for whom no adequate treatment options exist.

Our dynamic, industry-experienced team is growing. The CMC team is seeking a highly motivated, independent Associate Director / Director of Global Supply Chain who desires to be part of an energetic, fast-paced and collaborative team. The immediate focus is to continue to drive our two programs: moving one lead drug candidate through later-stage manufacturing, including building global supply chain capabilities, and moving another lead drug candidate through IND filing and initial clinical supply.

The successful candidate will work closely with the Senior Director of CMC to develop and execute the supply chain strategies for Q32’s biologics portfolio. The Associate Director / Director of Global Supply Chain will design, build, and implement supply chain strategy, processes, and systems. They will oversee all aspects of supplier management, supply chain logistics, and storage. They will collaborate withQ32’s clinical and CMC teams, as well as external manufacturing partners to ensure reliable, high-quality supply of global GMP clinical trial material while preparing for commercialization.

RESPONSIBILITIES:

• Establish and lead supply chain strategies and manage Q32’s network of suppliers for pack/label/kit, shipping, and third-party logistical services
• Collaborate with cross-functional stakeholders to select CMOs, establish contracts, and oversee manufacturing partners and suppliers
• Build and lead robust end-to-end supply chain business processes including supply planning, materials management, inventory management, logistics/distribution, and trade compliance
• Plan, coordinate, and lead all aspects of shipment of non-GMp and GMP materials with CDMOs
• Create and advance analytical capabilities and tools to shape Q32’s mid- to long-range clinical and commercial sourcing strategies, capacity plans, inventory strategies, and risk mitigation activities
• Assist in preparation of CMC regulatory documents
• Assist due diligence efforts, audits and site visits
• Serve as person-in-plant (PIP) and represent Q32 for pack/label/kit campaigns
• Interface with Quality and Regulatory teams and support Q32’s rigorous quality and regulatory systems and standards

• Prevent and resolve operational issues e.g. deviations, corrective and preventive actions, production delays etc.
• Effectively work within cross-functional teams to achieve corporate and program goals
• Understand and efficiently communicate project status and risks, present data and strategy
• Assist in the incorporation of knowledge of current regulations, guidance and competitive environment into company culture

REQUIREMENTS/QUALIFICATIONS:

• BS/MS/PhD in chemical/biological engineering or similar field
• 12+ years relevant industry experience
• Understanding of quality assurance and quality control cGMP production requirements
• Proven success in applying operations strategy, outsourcing, supply planning, materials management, and logistics experience to guide biologics programs through clinical development
• Ability to support optimization of manufacturing processes and oversee manufacturing campaigns to generate materials enabling GLP toxicology studies and clinical trials
• Skilled at leading cross-functional teams, gaining consensus, influencing outcomes, and collaborating effectively in a fast-paced work environment
• Experience in project and budget execution, negotiating service agreements and managing external vendors
• Understanding of regulatory requirements related to pharmaceutical development, manufacturing and specifications
• Exceptional attention to detail
• Ability to proactively identify issues and mitigate risks
• Ability to travel up to 20% of time